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Catalog Number ECH060040 |
Device Problems
Peeled/Delaminated (1454); Obstruction of Flow (2423)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 12/03/2021 |
Event Type
malfunction
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Event Description
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It was reported to gore that the patient underwent surgical treatment for a dialysis shunt in the left forearm with a gore® acuseal vascular graft.It was stated that the vascular graft was implanted on (b)(6) 2021, as a loop shunt for av access.On (b)(6) 2021, the shunt occluded.The physician stated that a delamination of the graft appeared to be seen.The graft remained implanted.Reportedly, the patient received a central venous line and is treated in the (b)(6).
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Manufacturer Narrative
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As the device remains implanted, no further investigation of the device can be performed.An image was provided for further evaluation.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Manufacturer Narrative
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Product history review: a review of the manufacturing - and heparin coatings records indicated the lots met all pre-release specifications.As the device remains implanted, no further investigation of the device can be performed.Imaging evaluation: the image provided by the complainant reflects the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.With the information provided to gore, the cause of the reported issue could not be established.In the instruction for use for the gore® acuseal vascular graft the following is stated: technical information: patients should be carefully monitored when using gore® acuseal vascular grafts for vascular access.Puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may lead to disruption of the graft material or formation of a perigraft hematoma or pseudoaneurysm.Possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis; mechanical disruption, formation of pseudoaneurysms due to excessive, localized, or large needle punctures.
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Manufacturer Narrative
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H6: evaluation codes medical device problem code a040506 was added.
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Search Alerts/Recalls
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